SOURCE: EXTEDO

November 29, 2010 08:00 ET

EXTEDO Announces New Version of eCTD Validation Tool

Free Download Includes Validation Rule Sets for the FDA, Croatia and Veterinary Submissions

MUNICH/OTTOBRUNN, GERMANY--(Marketwire - November 29, 2010) - EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced that a new version of EURSvalidator, a validation tool for eCTD, NeeS, and eNTA can be downloaded for free at the new EXTEDO website. The new version includes validation rule sets for the FDA, Croatia and veterinary submissions. An enhanced reporting capability in the new version allows users to sort validation results.

EURSvalidator 1.5 is integrated into the EURS is Yours™ solution, which is being used by more than 25 regulatory authorities worldwide. Using EURSvalidator 1.5 in advance of submitting electronic submissions minimizes the risk of failing technical validation at the regulatory authorities.

The complexity of submitting electronic dossiers in Europe is unique across the ICH regions, and can only be managed efficiently by providing clear and automated validation criteria.

EURSvalidator 1.5 supports the following formats:

  • CH eCTD (DTD version 1.0, version 1.0.1, and version 1.1)

  • EU eCTD (DTD version 1.2.1, version 1.3, and version 1.4)

  • EU NEES (Specification version 1.0)

  • HR eCTD (DTD version 1.4)

  • HR NEES

  • US eCTD (DTD version 2.01)

  • Veterinary eNTA immunological product (DTD 0.9)

  • Veterinary eNTA pharmaceutical product (DTD 0.9)

To download and install EURSvalidator 1.5 click here and follow the instructions.

"We have made some significant enhancements to this new version of EURSvalidator," said Tore Bergsteiner, CEO for EXTEDO. "The version that is available on our website for users to download at no charge uses the same validation engine used by most of the European regulatory authorities. The latest version not only upgrades the number of supported countries, it also includes a veterinary rule set that opens up a new area of coverage."

About EXTEDO

EXTEDO is the key solutions and services provider in the field of eRegulatory Affairs. The complete EXTEDOsuite is unique in all that it covers: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labelling Management, and Document Management.

EXTEDO provides configurable off-the-shelf products, as well as customized and integrated solutions. EXTEDO also provides EURS is Yours, the validation, review and approval system for the EMA and more than 25 Regulatory Authorities worldwide.

Today EXTEDO serves more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multi-national organizations. EXTEDO operates in the following markets for human, veterinary and crop protection: Life sciences, including pharmaceutical, biotech and biopharma, generics, homeopathics and medical devices, healthcare, and public sector. EXTEDO is recognized as the worldwide leader in each of its areas of operation.

For more information visit www.extedo.com.

All trade names, trademarks, and service marks are the rightful property of their respective owners.

Contact Information

  • Media Contact:
    Michael Kane
    EXTEDO
    Tel: 1-978-257-2179
    Email: Email Contact